|Obesity drug linked to suicides taken off the market
An anti-obesity drug taken by almost 100,000 patients in the UK will be taken off the market after five suicides within just
three months. Telegraph | October 23, 2008
Telegraph | October 23, 2008
Rimonabant, also known as Acomplia, was hailed as a wonder drug that would help obese people lose weight and stopped the urge to smoke when it was launched in 2006.
The European drugs regulator has recommended suspending its licence after new information revealed it doubled the risk of psychiatric disorders. Five people on the drug killed themselves compared to one on the group taking a dummy drug between June and August this year during a trial involving 36,000 patients.
Amongst the 97,000 people who have taken the drug since it was launched in the UK there has been one suicide and 1,146 reports of psychiatric problems suspected by doctors to be linked to Acomplia.
The drug was never approved in America because of concerns over the side effects.
All patients who are currently taking the drug are advised to see their doctor about an alternative but there will be no adverse effects if they stop taking Acomplia.
The European Medicines Agency's Committee for Medicinal Products for Human Use found that the drug is only moderately effective in weight loss, especially as many patients stop taking it after only a short period.
The number of patients reporting psychiatric problems such as depression, insomnia and suicidial thoughts also appeared to be higher in real life use than had been found in clinical trials.
The Committee was also concerned that some patients taking anti-depressants were still being prescribed Acomplia, despite strong warnings not to use it in this group being added to the packaging and guidelines for use last year.
A spokesman for the European Medicines Agency said: "Prescribers should not issue any prescriptions for Acomplia and should review the treatment of patients currently taking the medicine. Patients who are currently taking Acomplia should consult their doctor or pharmacist at a convenient time to discuss their treatment.
"There is no need for patients to stop treatment with Acomplia immediately, but patients who wish to stop can do so at any time.
"The CHMP opinion will now be sent to the European Commission for the adoption of a decision, applicable in all EU countries."
Dr June Raine, Director of Vigilance and Risk Management of Medicines at the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) said: "Following the European Medicines Agency decision to suspend the medicines licence for Acomplia, the MHRA is informing UK healthcare professionals not to give any new prescriptions for Acomplia and that they should review the treatment of patients currently taking the medicine. Patients who are currently taking Acomplia should consult their doctor or pharmacist at a convenient time to discuss their treatment.
"Most medicines work well and are acceptably safe and most people take medicines without suffering any side effects. The MHRA and the EMEA work together to continuously monitor the safety and quality of medicines after they have been licensed, and use a range of approaches to minimise risk. In the case of Acomplia these measures have not proved to be effective in clinical use."
Makers of the drug Sanofi-Aventis hope the drug can still be used and will continue research.
A spokeswoman stressed that the suspension of the licence is temporary.
In a statment issued by Sanofi-Aventis, Prof Robert Anthenelli, Professor of Psychiatry, Psychology and Neuroscience at the University of Cincinnati and Cincinnati Veterans Affairs Medical Centre, said: "This first in its class medication continues to demonstrate great promise to reduce cardiometabolic risk and the pattern of side effects remains consistent across the randomised clinical trials conducted to date. As with any new drug category, more will be learned about optimising benefit and minimising risk through continuing controlled use of the medication in different patient populations. While the pendulum has swung in the direction of extreme caution with today's regulatory decision, at the end of the day, the medical community will allow the scientific process to unfold before rendering any final decisions about this medication's ultimate therapeutic potential."
Meanwhile another obesity drug, orlistat, marketed as Alli, will be made available without prescription.
It is the first time the European drug regulator has recommended such a switch from prescription-only and comes after makers, GlaxoSmithKline, produced a lower dose version which has fewer side effects. In the UK it is likely that people will be able to buy Alli from a pharmacist.
Alli should be used in conjunction with diet and exercise for the treatment of people who have a Body Mass Index of 28 or higher, the equivalent of a 5ft 5' woman weighing more than 12st 1lb.